Impact of Out-of-Pocket Pharmacy Costs on Branded Medication Adherence Among Patients with Type 2 Diabetes.

BACKGROUND: Medication adherence is pivotal for the successful treatment of diabetes. However, medication adherence remains a major concern, as nonadherence is associated with poor health outcomes. Studies have indicated that increasing patients' share of medication costs significantly reduces adherence. Little is known about a potential out-of-pocket (OOP) cost threshold where substantial reduction in adherence may occur. OBJECTIVE: To examine the impact of diabetes OOP pharmacy costs on antihyperglycemic medication adherence and identify the potential threshold at which significant reduction in adherence may occur among patients with type 2 diabetes mellitus (T2DM). METHODS: This was an observational, retrospective cohort study using longitudinal U.S. pharmacy and medical claims data from the IMS Health Medical Claims (Dx) database. Patients with T2DM who initiated therapy with a branded antihyperglycemic medication during the index period (January 1, 2011, to December 31, 2011) and had 3 years of follow-up data were included. The primary outcome was adherence to antihyperglycemic medications, measured as the number of days covered. Propensity scores were calculated using baseline sociodemographic and clinical characteristics to control for potential confounding factors. Four strata were created based on mean propensity scores. Across each stratum, patients were assigned to 5 diabetes OOP pharmacy (including generics) cost levels: $0-$10, $11-$40, $41-$50, $51-$75, and > $75. Multivariate regression models were used to estimate association of diabetes OOP pharmacy costs and adherence for each stratum. Sensitivity analyses were conducted to assess the impact of total OOP pharmacy costs and index drug category OOP costs on adherence. RESULTS: A total of 15,416 patients were assessed. Across each stratum in the diabetes OOP pharmacy cost analysis group, mean patient age ranged from 52.3 to 56.1 years, mean number of antihyperglycemic medication classes ranged from 1.5 to 3.2, and mean household income ranged from $60,763 to $79,373. Most patients used a commercial plan (55%-85%). The propensity-stratified multivariate regression model revealed an overall negative relationship between diabetes OOP pharmacy costs and adherence across several OOP cost levels. Diabetes OOP pharmacy cost level $51-$75 appeared as the threshold at which adherence reduced significantly (77-78 fewer days of coverage over 3 years of follow-up; P < 0.05) when compared with the lowest OOP costs ($0-$10) across all strata. Adherence reduced further (99-145 fewer days of coverage; P < 0.0001) for the higher diabetes OOP pharmacy cost levels (> $75) when compared with the lowest OOP cost levels. Sensitivity analyses with total OOP pharmacy costs and index drug category OOP costs revealed negative association with adherence across all strata. CONCLUSIONS: Diabetes OOP pharmacy cost was negatively associated with patient adherence, and a potential OOP cost threshold ($51-$75) was identified at which adherence reduced significantly. The study findings may be beneficial in informing the design of health care plans to achieve optimal adherence and improve disease management in patients with T2DM. DISCLOSURES: This study was funded by Eli Lilly and Company. Eli Lilly and Company was involved in the study design; collection, analysis, and interpretation of data; preparation of the manuscript; and decision to submit for publication. Fu is an employee of Eli Lilly and Company. Taylor and Kwan are employees of Lilly USA. Fu and Kwan hold stock or stock options in Eli Lilly and Company. Bibeau was an employee of Eli Lilly and Company at the time of this study and initial submission of this manuscript. Bibeau is currently employed by Janssen Scientific Affairs. The abstract for this study was presented at the AMCP Managed Care & Specialty Pharmacy Annual Meeting 2016; April 19-22, 2016; San Francisco, California. Bibeau and Fu contributed to the study design and collected the data. All authors contributed equally to data interpretation and manuscript preparation and revision.

Cardiovascular fitness moderates the relations between estimates of obesity and physical self-perceptions in rural elementary school students.

BACKGROUND: Levels of physical activity decline throughout childhood. Children's physical self-perceptions have been found to relate to their physical activity. Understanding the relationships among physical self-perceptions, obesity, and physical activity could have important implications for interventions in children. METHODS: The current study investigated the moderating effect of cardiovascular fitness (CVF, heart rate recovery from a 3-minute step test) on the relationship between obesity (BMI, waist circumference) and physical self-perceptions (athletic competence, physical appearance) in 104 fourth- and fifth-grade children from a small rural community. RESULTS: Hierarchical regression analyses indicated that CVF moderated the relations between BMI and waist circumference on athletic competence. For children with lower fitness, higher waist circumference was associated with lower athletic competence, while for children with higher fitness levels, higher BMI was associated with higher athletic competence. Results also indicated that both BMI and waist circumference were negatively related to physical appearance. CVF moderated these relations such that only children with lower fitness, greater BMI and waist circumference was associated with poorer physical appearance scores. CONCLUSIONS: Implications include the need for support of fitness programs to promote psychological well-being and to investigate the relationship between obesity and physical self-perceptions within the context of fitness.

Perceptions of the food marketing environment among African American teen girls and adults.

Obesity disproportionately affects African American adolescents, particularly girls. While ethnically targeted marketing of unhealthful food products contributes to this disparity, it is not known how African Americans perceive the food marketing environment in their communities. Qualitative methods, specifically photovoice and group discussions, were used to understand perceptions of African American adults and teen girls regarding targeted food marketing to adolescent girls. An advisory committee of four students, two faculty, and two parents was formed, who recruited peers to photograph their environments and participate in group discussions to answer "what influences teen girls to eat what they do." Seven adults and nine teens (all female) participated in the study. Discussions were transcribed, coded, and analyzed with ATLAS.ti to identify common and disparate themes among participants. Results indicated that adults and teens perceived the type of food products, availability of foods, and price to influence the girls' choices. The girls spoke about products that were highly convenient and tasty as being particularly attractive. The adults reported that advertisements and insufficient nutrition education were also influencers. The teens discussed that the places in which food products were available influenced their choices. Results suggest that the marketing of highly available, convenient food at low prices sell products to teen girls. Future work is needed to better understand the consumer's perspective on the food and beverage marketing strategies used.

Assessment of Treatment Patterns and Patient Outcomes in Levodopa-Induced Dyskinesias (ASTROID): A US Chart Review Study.

BACKGROUND: No curative therapy is available for Parkinson's disease; therefore, one of the main goals of treatment is to control motor symptoms, often via the use of levodopa (also known as L-dopa). However, prolonged levodopa treatment in Parkinson's disease has been associated with the development of motor fluctuations and the occurrence of levodopa-induced dyskinesias (LIDs). OBJECTIVE: To gain a clear, empirical understanding of the current real-world approach to treatment and patient outcomes associated with Parkinson's disease and LIDs. METHODS: This study used a mixed methodology, combining a cross-sectional survey of neurologists practicing in the United States, a retrospective chart review of patients with Parkinson's disease and LIDs, and cross-sectional surveys of health-related quality of life (QOL) and physical functioning in patients with Parkinson's disease. The surveys included the 39-item Parkinson's Disease Questionnaire, the Unified Parkinson's Disease Rating Scale, the Parkinson Disease Dyskinesia 26-item Scale, and the modified Abnormal Involuntary Movement Scale (mAIMS). Survey and chart data were collected between May 2010 and July 2011. Descriptive analyses were used to evaluate the distribution of study variables, treatment patterns, patient QOL, and patient physical functioning. RESULTS: Data from 7 neurologists and from 172 patients with Parkinson's disease and LIDs were collected. Results from the physician survey indicate that prescribing patterns depend largely on the severity of LIDs, assessed via mAIMS. Most patients (88%) received pharmacologic therapy as first-line treatment for LIDs, with monotherapy favored in patients with mild LIDs and combination therapy in patients with moderate-to-severe LIDs. The mean time from the diagnosis of LID to the administration of first-line treatment for the condition was 10.7 months (standard deviation, 14.0 months). The study population reflects a mean time from levodopa initiation to the onset of LIDs of slightly more than 5 years, regardless of the levodopa dosage. Results from the chart review and the physician survey suggest a strong alignment in severity classification among the assessment scales used. CONCLUSION: These findings indicate that the diagnosis and the treatment of Parkinson's disease and LIDs are not optimal, because of the length of time from diagnosis to treatment, and because of the variability in treatment selection and response. Additional real-world studies are recommended to better understand treatment patterns, compliance with guidelines, and their potential impact on patient outcomes.

Effects of a 12-week resistance exercise program on physical self-perceptions in college students.

There is an increase in literature suggesting exercise can promote positive changes in physical self-perceptions that can manifest as an increase in global self-esteem. In the present study, we assessed self-esteem using the hierarchical framework of the Exercise and Self-Esteem Model (EXSEM) along with cognitive facets at the subdomain level (e.g., competence, certainty, importance, and ideal self-discrepancy). This allowed for an analysis of cognitive facets as possible contributors to changes in physical self-perceptions. We addressed these aims with a sample of 120 college-age adults who completed a 12-week resistance exercise program. Results indicated significant improvements in self-perception constructs at all levels of the EXSEM. The hierarchical structure of the EXSEM was partially supported, as we observed successively smaller improvements at each level of the model (e.g., self-esteem showed lesser improvements than physical self-worth). In addition, a path model developed to explain the impact of strength changes on self-esteem proved a good fit for the data. Results are discussed in terms of contemporary models of self-perception, potential mediators of exercise on self-esteem, and the need to consider cognitive facets of self-perception.

Prehabilitation before total knee arthroplasty increases strength and function in older adults with severe osteoarthritis.

Preparing for the stress of total knee arthroplasty (TKA) surgery by exercise training (prehabilitation) may improve strength and function before surgery and, if effective, has the potential to contribute to postoperative recovery. Subjects with severe osteoarthritis (OA), pain intractable to medicine and scheduled for TKA were randomized into a usual care (UC) group (n = 36) or usual care and exercise (UC + EX) group (n = 35). The UC group maintained normal daily activities before their TKA. The UC + EX group performed a comprehensive prehabilitation program that included resistance training using bands, flexibility, and step training at least 3 times per week for 4-8 weeks before their TKA in addition to UC. Leg strength (isokinetic peak torque for knee extension and flexion) and ability to perform functional tasks (6-minute walk, 30 second sit-to-stand repetitions, and the time to ascend and descend 2 flights of stairs) were assessed before randomization at baseline (T1) and 1 week before the subject's TKA (T2). Repeated-measures analysis of variance indicated a significant group by time interaction (p < 0.05) for the 30-second sit-to-stand repetitions, time to ascend the first flight of stairs, and peak torque for knee extension in the surgical knee. Prehabilitation increased leg strength and the ability to perform functional tasks for UC + EX when compared to UC before TKA. Short term (4-8 weeks) of prehabilitation was effective for increasing strength and function for individuals with severe OA. The program studied is easily transferred to a home environment, and clinicians working with this population should consider prehabilitation before TKA.

Effects of acute resistance training of different intensities and rest periods on anxiety and affect.

The affective benefits associated with aerobic exercise are well documented. However, literature concerning resistance exercise has suggested a more variable response (i.e., a short duration increase in state anxiety, which eventually is reduced below baseline) and thus may play an important role in the adoption and maintenance of a resistance training program. The purpose of the current study was to examine the effects of different intensities and rest period during resistance exercise on anxiety, positive affect, and negative affect while holding volume constant and controlling for self-efficacy. Using an experimental design, individuals enrolled in a weight training class (n = 104) were randomly assigned 1 of 5 exercise conditions (control, low-long, low-short, high-long, and high-short), varying intensities, and rest time. Anxiety and positive and negative affect measurements were collected immediately following the exercise workouts. Data from separate analyses of covariance revealed a significant main effect for condition on positive affect (p = 0.026), in which the low-long group reported significantly higher positive affect than the control group, at 5-minute postexercise. Similar analysis indicated a significant main effect for time on anxiety (p = 0.003), with the highest anxiety detected at 5-minute postexercise, and significant reductions in anxiety at both 20-minute and 40-minute postexercise. In conclusion, these results suggest that the variation of intensity and rest time had a modest short-term effect on psychological states, following an acute bout of resistance exercise. Personal trainers and health professionals may want to emphasize light-intensity resistance programs for novice clients to maximize psychological benefits, which in turn, may positively affect compliance and adherence.

Case study of a transtheoretical case management approach to addressing childhood obesity.

Childhood obesity is an increasing health concern that is strongly associated with chronic health problems persisting into adulthood. Obesity in childhood is resistant to interventions that involve only recommendations to decrease caloric intake and to increase caloric expenditure. The challenge with this approach to childhood obesity is twofold: It is neither theoretically based nor does it consider the children's or their parent's perceptions of their health problems. Of significance, this traditional approach also ignores the transition along the stages of behavioral change. Case management has proven to be successful in managing various chronic health problems in both adults and children. This case study will present a new intervention model to treat childhood obesity based on the transtheoretical framework utilizing case management in a primary care setting.